MynxGrip Vascular Closure Device (5F, 6F/7F)
FDA premarket approval P040044/S104 · decided 2024-10-09
Approval details
- PMA number
- P040044
- Supplement
- S104
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MynxGrip Vascular Closure Device (5F, 6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2024-09-10
- Decision date
- 2024-10-09
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for changes to the instructions for use, carton label and patient implant card to enhance the safe use of the device, and to comply with the current standards, EU Medical Device Regulations and UK Medical Device Regulations
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